FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
84721–84744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1999
TELEMEDICINE 2000
K992164 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 66d
Cleared Aug 30, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE
K992223 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 60d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
K992241 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
K992243 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
EASY-CURE (CURING AND WHITENING LIGHT)
K992357 · EBZ
Ics of North America, Inc.
Dental · 47d
Cleared Aug 30, 1999
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K992430 · JJT
Medical Analysis Systems, Inc.
Toxicology · 40d
Cleared Aug 30, 1999
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992463 · LYZ
Shijiazhuang Dilly Plastics Products...
General Hospital · 38d
Cleared Aug 30, 1999
MEDIFIX INC.
K992483 · FAJ
Medifix, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 30, 1999
TOF-WATCH S
K992596 · KOI
Organon Teknika Corp.
Anesthesiology · 27d
Cleared Aug 30, 1999
TOF-WATCH SX
K992598 · KOI
Organon Teknika Corp.
Anesthesiology · 27d
Cleared Aug 27, 1999
REPOSE BONE SCREW SYSTEM
K981677 · LRK
Influence, Inc.
Dental · 472d
Cleared Aug 27, 1999
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
K982208 · ITX
Jomed Imaging , Ltd.
Radiology · 430d
Cleared Aug 27, 1999
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · MQX
Sedatelec
General Hospital · 303d
Cleared Aug 27, 1999
DN ACUPUNTURE NEEDLES
K983800 · MQX
Sedatelec
General Hospital · 303d
Cleared Aug 27, 1999
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
K990261 · LZO
Plus Orthopedics
Orthopedic · 212d
Cleared Aug 27, 1999
CERSR ELECTROMYOGRAPHY SYSTEM
K990766 · IKN
Paraspinal Diagnostic Corp.
Neurology · 172d
Cleared Aug 27, 1999
TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC...
K990785 · GCJ
Jakoubek Medizintechnik GmbH
General & Plastic Surgery · 171d
Cleared Aug 27, 1999
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990903 · GEX
Laserscope
General & Plastic Surgery · 162d
Cleared Aug 27, 1999
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055 · MNH
Howmedica Osteonics Corp.
Orthopedic · 150d
Cleared Aug 27, 1999
SYNTHES CERVIFIX SYSTEM
K991089 · KWP
Synthes Spine
Orthopedic · 149d
Cleared Aug 27, 1999
DYNA-LOK PLUS SPINAL SYSTEM
K991198 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 141d
Cleared Aug 27, 1999
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · MQX
Helio Medical Supplies, Inc.
General Hospital · 120d
Cleared Aug 27, 1999
ACUMASTER BRAND ACUPUNCTURE NEEDLE
K991508 · MQX
Helio Medical Supplies, Inc.
General Hospital · 120d